Zobel signals she’ll reject Patrick’s action on Zohydro

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A federal judge said Tuesday that she will probably strike down Governor Deval Patrick’s emergency ban on the sale of Zohydro, a controversial painkiller that has been approved by federal regulators but that critics say is highly addictive.

US District Court Judge Rya W. Zobel gave state lawyers until Monday to further research their defense of the governor’s ban, but she indicated that she would grant a preliminary court injunction on behalf of the drug’s maker that would allow Zohydro’s sale in Massachusetts.

“I think, frankly, the governor is out of line on this,” an irritated Zobel said from the bench.

Patrick, in declaring a state of emergency in late March that was aimed at confronting the state’s burgeoning opiate overdose crisis, had banned prescription and sale of hydrocodone-only drugs, a category that only includes Zohydro. The governor said the ban would remain in effect until proper safeguards, such as making the drug crush-resistant, so it could not be snorted or injected by drug addicts, are put in place.

The drug has not yet been sold in the state.

Zobel appeared annoyed that Patrick had imposed the ban without first contacting the drug maker, Zogenix Inc., which has argued that the ban violates its constitutional rights. She urged lawyers for the state and the firm to meet before a hearing she set for Monday, but said the company “probably will prevail.”

Patrick said after Tuesday’s hearing that he banned the drug because he was confident he was on firm legal footing.

“And, more to the point, I wouldn’t have done it if I didn’t think we had a real emergency,” Patrick told reporters. “And we have a real emergency. Zohydro is not the center of that emergency [but] it’s an example of a highly addictive painkiller, and it’s one of the few that is not in an abuse-resistant form. Put it in an abuse-resistant form, and I and many others will make our peace with it.”

Stephen J. Farr, president of the California-based Zogenix, said outside the courthouse that he welcomed Zobel’s stand on the case, saying he has already proved the drug’s worth and safety before the Food and Drug Administration, the country’s drug regulator. Lawyers for Farr said they could find no other case in which a state governor sought to overturn a decision by the federal agency.

“We came here today because we felt the governor, through his order, was harming our company, certainly hurting the patients of Massachusetts,” Farr said.

The drug has come under intense scrutiny since it was first approved for sale by the FDA in October, for patients requiring consistent painkiller therapy. The company contends that it has already undergone a strict 18-month screening process and that the drug was approved with tighter oversight than other drugs, such as Vicodin.

The company also says that Zohydro is safer than other hydrocodone drugs that contain acetaminophen, because it avoids the potential for toxic doses of acetaminophen over a long period, which can cause liver damage and liver failure.

Zogenix has said that abuse-deterrent formulations of the drug are in the early stages of development, but that the FDA has already granted approval of Zohydro for its immediate use. In March, the company took the unusual decision to assemble an oversight board to monitor use of the drug.

Critics worry that the drug will add to the state’s and region’s growing epidemic of opioid abuse. The pill contains up to five times more hydrocodone than Vicodin.

The Centers for Disease Control and Prevention has highlighted the need to prevent prescription painkiller abuse, reporting a jump from 4,030 deaths in 1999 to 16,651 deaths in 2010.

Earlier this month, Vermont passed an emergency order that would make it harder for doctors to prescribe Zohydro, requiring providers to conduct a tighter risk assessment before prescribing the drug.

Meanwhile, 28 state attorneys general signed a letter asking the FDA to revoke the drug’s approval or require Zogenix to make it more difficult to crush the drug.

US Representative Stephen F. Lynch has cosponsored legislation that would force the FDA to withdraw approval of the drug.

Steven Hollman, an attorney for Zogeniz, told Zobel that four prescriptions for Zohydro had been written in Massachusetts before the governor’s ban went into effect, but the drugs were not dispensed. He said thousands of patients could qualify for the painkiller.

Jo Ann Shotwell Kaplan, an assistant state attorney general, argued that thousands of people have died of opiate overdoses and that Patrick targeted Zohydro because of the growing epidemic.

Zobel, however, pointed out that the state could not attribute the epidemic to Zohydro, which has not yet been prescribed in the state.

“Massachusetts has not made stricter regulations on the drug; it has banned the drug, all together, for people who may need it,” she said, adding, “Can you find a single case where a governor has overruled the FDA?”